On March 21, the Department of Health (DOH) announced that the new VBP system will build on NICE's existing appraisal
processes but will also be "capable of incorporating a broader assessment of a medicine's benefits and costs, taking into
account factors such as burden of illness and wider societal benefits."
But while this "last minute" confirmation of NICE's role within VBP may have satisfied the short-term demands of the Health
Select Committee, it has not done much to clarify the key issues surrounding VBP.
The desire on the part of the DOH to demonstrate progress on VBP is understandable, says Birtwistle, but genuine progress
isn't apparent. He adds that much of "the running (and thinking) remains to be done," (March 27, 2013).
For one, the term "value" itself remains elusive. As Meir Pugatch of Pugatch Consilium asserts: "Value is perceived very
differently by the different players involved in the process, namely policymakers, producers, and, not least, patients."
Policymakers have displayed a tendency to attach a "more static meaning" to value, says Pugatch—"defined narrowly as value
for money at a given point in time and in light of the desire to reduce or control costs." Such an approach to VBP, he goes
on, "presumes a priori that a new drug has already been created. Payers do not attach value to the time, costs, and risks associated with the creation
of the new drug, but rather only to its therapeutic outcomes compared with other treatments."
For Pugatch, the decision to place VBP firmly within NICE suggests that "the traditional 'realpolitik' approach to value is
most likely to hold sway." The result will be that the United Kingdom is less well placed to become the source of the next
new wave of innovative medicines.
Pray for delay?
NICE itself hasn't exactly helped to soothe the ongoing VBP anxiety; two weeks after the DOH's announcement, its own chief
executive, Sir Andrew Dillon, told reporters: "I don't know very much more than what is in the public domain and the statements
that have been made."
He went on to speculate that if VBP is to be "a radically different system, then whoever is involved in it is going to
have to move very quickly." On the other hand, if it is "more of an evolution of the current arrangement, then it may be easier
to see how 2014 is a more realistic prospect."
Such comments are unlikely to placate those calling for transparency and urgent clarification of the VBP process. Indeed,
"evolution of the current arrangement" suggests that those predicting VBP will simply be a modified version of the PPRS may
be right. Certainly, Dillon's uncertainty gives rise to the argument that a delay to the proposed January 2014 start date
for VBP is inevitable.
For health economist Leela Barham, however, delaying VBP "could make a lot of sense." It would allow for efforts to improve
access through innovation, health and wealth, such as automatic updating of formularies, to become established. Unfortunately,
the opportunity to delay VBP "quietly" is impossible now following the Heath Select Committee's high profile criticisms. There
is a chance though, she adds, that VBP could be introduced "in a phased way, tested on a few new products rather than all
new products from January 2014." But one of the problems with this method is how to decide "who gets to be the guinea pig!"
A delay would however mean further uncertainty with regard to medicines funded by the Cancer Drug Fund (CDF), which, like
the PPRS, is set to close in 2014. The fund covers the cost of cancer treatments that NICE has either rejected or not yet
decided on. (By December 2011 the fund had made around 10,000 treatments available to patients in England, covering 34 products.)
"The CDF is supposed to be a 'bridge' to VBP," says Barham. If VBP solves the perceived problems with NICE in making recommendations
on new medicines, then such a fund would not be needed. But the current lack of detail on VBP again leaves this situation
Whatever the progress (or lack of it) on VBP, NICE's future, at least, seems assured. With effect from April 1, its status
changed from a strategic health authority to an executive, non-departmental public body, with new, added responsibility for
developing "guidance and quality standards for social care" and encouraging the "better integration of health and social care
services." The acronym remains the same, but NICE now stands for National Institute for Health and Care Excellence (after
eight years as the National Institute for Health and Clinical Excellence). And with the new remit comes new blood; Sir Michael
Rawlins, NICE's chair since its formation 14 years ago, has stepped down to make way for Professor David Haslam, who, alongside
more elevated positions, spent 36 years at the coalface of general practice as a primary care physician.
In Haslam's first announcement as chair he admitted that tough challenges lie ahead for the expanded NICE. Forging ahead
with workable approach to VBP will be just one of them.
Julian Upton is Pharm Exec's European Editor. He can be reached at email@example.com